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Latest From Amgen, Inc.
Takeda’s TAK-721 is back, ARS Pharma will be back soon to appeal neffy complete response letter, US FDA’s Project Renewal brings Temodar labeling in current day, and more highlights from the Pink Sheet’s US FDA Performance Tracker.
Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.
- Specialty Pharmaceuticals
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- Amgen K.K.
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- deCODE Genetics
- Dezima Pharma B.V.
- Five Prime Therapeutics, Inc.
- Immunex Corporation
- KAI Pharmaceuticals
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